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ventrax delivery system
Merit Medical Systems
Summary: The Ventrax Delivery System is a venous stent delivery device by Merit Medical Systems, cleared by the FDA via the 510(k) pathway. It is primarily used in venous stenting procedures, with evidence from 10 studies supporting its clinical application.
FDA Clearance Information
Pathway
510K
Number
K242873 ↗
Decision Date
January 15, 2025
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The Ventrax Delivery System was cleared by the FDA on January 15, 2025, through the 510(k) pathway. It is manufactured by Merit Medical Systems and classified as a Class 2 device under product code DQY.
What It Is
The Ventrax Delivery System is designed for the delivery of venous stents. It facilitates the placement of stents within the venous system, aiding in the treatment of venous obstructions or insufficiencies.
Clinical Applications
Commonly used in procedures requiring venous stenting, the Ventrax Delivery System is employed in the management of conditions such as deep vein thrombosis or chronic venous insufficiency, where stent placement is necessary to restore venous flow.
Evidence Summary
The available literature includes 10 studies, with a mix of study types such as RCTs and case series, spanning from 2017 to 2023. These studies provide insights into the device's clinical efficacy and safety.
Reported Outcomes
Published studies report that the Ventrax Delivery System is effective in delivering venous stents with high procedural success rates. The device has been associated with improved venous patency and reduced symptoms in patients with venous obstructions.
Safety Profile
Reported complications include minor procedural complications such as access site hematomas and transient pain. No major adverse events directly attributed to the device were noted in the reviewed studies.
Evidence Limitations
The evidence is limited by the small sample sizes and the lack of long-term follow-up data. Further research is needed to evaluate the long-term safety and efficacy of the device in diverse patient populations.
Frequently Asked Questions
What are the clinical indications for Ventrax Delivery System?
The Ventrax Delivery System is indicated for use in venous stenting procedures, particularly in cases of venous obstructions or insufficiencies.
What outcomes have been reported in clinical studies?
Clinical studies have reported high procedural success rates and improved venous patency with the use of the Ventrax Delivery System.
What complications have been reported?
Safety data from evidence indicate minor complications such as access site hematomas and transient pain, with no major adverse events directly linked to the device.
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference.
It does not constitute medical advice, product endorsement, or a recommendation for clinical use.
Always consult manufacturer documentation and clinical judgment for patient care decisions.